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Hydroxycut Diet Aids Recalled After Warning

Federal drug regulators warned consumers Friday to stop using the popular Hydroxycut line of weight-loss products, citing reports of a death due to liver failure and other instances of serious health problems.

The Hydroxycut brand, which has been widely sold at national chain stores including GNC and the Vitamin Shoppe, includes pills, drinks and powders marketed to increase energy, burn calories and fat, and control appetite. The maker reported selling more than nine million units of the brand last year, according to the F.D.A.

That company, Iovate Health Sciences of Oakville, Ontario, and its American distributor are voluntarily recalling 14 of the products. Two other products, Hydroxycut Cleanse and Hoodia, with different ingredients, are not affected by the recall. Calls to the company’s Canadian headquarters reached a recorded message that directed callers to the Hydroxycut Web site.

The recall of one of the best-known weight-loss brands is the latest in a series of incidents that raise the question of whether the Food and Drug Administration has adequate authority to regulate the dietary supplement industry and provide consumer protection.

At issue is the difference in the way the agency oversees drugs — defined as products that prevent or cure disease — and dietary supplements, which can offer general health benefits but cannot claim to treat specific diseases or symptoms.

Unlike drugs, whose manufacturers must provide safety and effectiveness data before receiving federal approval to sell the products, dietary supplements do not need F.D.A. approval to go on sale. Manufacturers of dietary supplements are themselves responsible for ensuring and documenting the safety and efficacy claims of their products.

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Hydroxycut is sold as pills, drinks and powders.Credit
William P. O’Donnell/The New York Times

According to the law governing dietary supplements, the F.D.A. is empowered to act only in cases when it identifies a harmful or adulterated product that is already on sale.

“Part of the problem as you know is that F.D.A. looks at dietary supplements from a postmarket perspective, so that an isolated incident is often difficult to follow,” Dr. Linda Katz, interim chief medical officer of the agency’s Center for Food Safety and Applied Nutrition, said Friday.

The agency has been on a campaign to identify and warn consumers about tainted weight-loss pills that illegally contain prescription drug ingredients. Since December, the F.D.A. has issued a list of 70 brands that contained hidden and potential hazardous drugs including an antiseizure medication.

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Representatives of the industry said that current regulations were adequate to protect consumers because manufacturers conducted their own safety tests.

“Nobody goes to market without testing,” said John Hathcock, vice president of scientific and international affairs at the Council for Responsible Nutrition, a trade group. He added that neither drug makers nor supplement manufacturers could ensure total product safety once an item moved from a testing lab into mass circulation.

The F.D.A. said that a new law that requires manufacturers to notify the agency of any reports of serious health problems helped officials identify a pattern of adverse events linked to Hydroxycut users. In addition, the agency cited reports in medical journals of serious liver disease being diagnosed in six people who had taken Hydroxycut.

The agency said the consumers were healthy before using Hydroxycut and took the recommended dose. Because the formula for Hydroxycut has changed over time and because the product contains different amounts of a proprietary blend of ingredients, the agency said it had not yet determined which of the product’s ingredients might constitute a health hazard.

Vitamin Shoppe and GNC said they were removing Hydroxycut products from their Web sites and stores. Several months ago, the companies stopped selling another well-known weight-loss brand, StarCaps, that was found to contain a powerful prescription diuretic.

A GNC spokeswoman wrote in an e-mail statement Friday, “As soon as we become aware of potential problems with any product, we take immediate action, as we have done in this situation.”

A version of this article appears in print on , on Page B3 of the New York edition with the headline: Hydroxycut Diet Aids Recalled After Warning. Order Reprints|Today's Paper|Subscribe